Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled at 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 144 analysis was on 26 June 2013.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

917 participants were screened and 707 were randomized. 700 randomized participants received at least one dose of study medication and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety Analysis Set: participants were randomized and received at least one dose of study medication.